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Results For "submission"

300 News Found

Savara resubmits FDA application for potential treatment in rare lung disease patients
Biopharma | January 01, 2026

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer


Establishment Labs seeks FDA nod for Motiva breast reconstruction implants
News | January 01, 2026

Establishment Labs seeks FDA nod for Motiva breast reconstruction implants

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation


Italfarmaco and JCR Pharmaceuticals partner to bring Duchenne therapy to Japan
News | December 30, 2025

Italfarmaco and JCR Pharmaceuticals partner to bring Duchenne therapy to Japan

The partnership also sets the stage for broader collaboration on rare disease treatments


INOVIO’s DNA therapy for rare throat disease gets FDA review
Biotech | December 30, 2025

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway


Next Gen Diagnostics to spin off infection prevention unit
News | December 29, 2025

Next Gen Diagnostics to spin off infection prevention unit

NGD Infection Prevention was formed to scale the delivery of sequence-based transmission detection


Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613
Biopharma | December 24, 2025

Ipsen acquires Simcere Zaiming’s innovative ADC SIM0613

The therapy targets the LRRC15 protein and is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.


Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant


Novo Nordisk files FDA application for once-weekly obesity drug CagriSema
News | December 19, 2025

Novo Nordisk files FDA application for once-weekly obesity drug CagriSema

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection


Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


Pharma overhaul: EMA hails “Once-in-a-Generation” reform
Policy | December 16, 2025

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU